Progress is slow on moving surplus H1N1 flu vaccine to countries in need

There is now so much unused H1N1 pandemic flu vaccine in the world that rich nations, including the United States, are trying to get rid of their surpluses. But the world’s poorest countries — a few still facing the brunt of the pandemic — are receiving very little of it, The New York Times reported Feb. 2.

Of the 95 countries that told the World Health Organization last year that they had no means of getting flu vaccine, only two, Azerbaijan and Mongolia, have received any so far. Afghanistan is expected to be next.

Early last month, WHO officials said they hoped to have shipped vaccine to 14 countries by now, and even then it would have been only enough to protect 2 percent of the countries’ populations.

While the flu has waned in North America, it is still affecting North Africa, Central Asia and parts of Eastern Europe. This imbalance between rich and poor countries, and the inefficiency of global vaccine transfers, frustrates many experts.

“If we’d been confronted with H5N1, we’d be completely caught with our pants down,” Dr. David S. Fedson, a former medical director for Aventis-Pasteur vaccines and an expert on pandemics, said, referring to the avian flu, which has a 60 percent mortality rate. “I don’t think any nation got it right.”

But the WHO is stuck with the world as it is: countries that can afford vaccines save themselves first and, when the worst has passed, transfer their leftovers to the poor, using the WHO as a clearinghouse.

That transfer “turns out to be an incredibly difficult logistical action,” said Dr. Keiji Fukuda, the WHO’s chief of pandemic influenza. “It’s a mammoth effort by an awful lot of people and organizations and countries but holy moly, it’s a very complex operation.”

Each country must submit a plan proving it can store refrigerated vaccine, give it to those who need it most, inject it safely and do medical follow-up. It must also sign letters exempting donors from legal liability, and the WHO has to certify the vaccine as safe if the country has no regulatory agency. Even shipping adds delays.

By December, Fukuda said, only five countries had even received syringes.

Bill Gates, who just pledged $10 billion, the largest charitable donation in history, to getting other vaccines to the poor, dismissed flu vaccine shipments as “a pipe dream.”

“It’s not practical; they have no infrastructure to deliver it,” he said. “And you don’t want to distract them away from measles vaccine, for example. That could cost lives.”

Although 190 million doses have been pledged to the WHO, it is not ready to use them. So rich countries are frantically trying to cancel orders.

The surplus built up because they put in orders when it was assumed that two doses would be needed to provide protection. For most people, only one was. Also, as the virus proved less lethal, many countries lost interest.

France, for example, ordered 94 million doses for its 65 million people. At first, there was deep skepticism; 80 percent of French residents polled said they would refuse. But after a few deaths were reported, such huge lines formed that, in Lyon, the riot police were called. Then interest faded; France has been trying to sell 50 million doses.

Other nations faced similar waves of skepticism, panic and yawns. In Britain, government experts predicted 65,000 deaths, then revised that to 1,000. Fewer than 400 died. The government is renegotiating contracts for 90 million doses.

CEO Daniel Vasella of the Swiss pharmaceutical company Novartis recently warned that governments breaking their contracts might not be first in line in the next pandemic.

“Reliable partners will be treated preferentially,” he said.

Canada recently lent Mexico 5 million doses because Mexico’s first shipments were not due to arrive until this month. Similar bilateral deals took place between Western and Eastern Europe, a WHO spokesman said.

The great exception is Poland, the only Western country known to have rejected H1N1 flu vaccine and to have spent nothing to stop the pandemic, according to The Associated Press. Poland had fewer than 150 confirmed deaths, and the government’s decision proved very popular, The AP said.

The United States has contracts to buy 251 million doses from five companies. With one exception — the cancellation of 22 million doses out of 36 million ordered from CSL Ltd., an Australian manufacturer that fell behind on deliveries anyway — those orders are going ahead.

Although critics have called that wasteful, because only about 62 million doses have been given, federal health officials are gambling that it is better to have a surplus in case a third wave emerges.

The country also promised 25 million doses to the WHO.

Dr. Bruce G. Gellin, director of the National Vaccine Program Office at the Department of Health and Human Services, defended the decision, noting that not all the vaccine would be put into vials, an extra step that involves a separate payment. Instead, it can remain in “bulk antigen” form.

Bulk antigen is not normally saved because flu mutates. But Gellin said tests on a stockpile of experimental vaccine against the H5N1 avian flu that the government began building in 2004 showed that it slowly loses potency but is still strong enough to be used.

The unused H1N1 flu antigen, he argued, could be quickly put in vials if a third wave emerged; shifted to the Southern Hemisphere, where the flu season starts in June; or saved for next year’s seasonal flu shots.